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Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Doubl...

FDA Device Recall #Z-1428-2018 — Class II — February 7, 2018

Recall Summary

Recall Number Z-1428-2018
Classification Class II — Moderate risk
Date Initiated February 7, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Halyard Health, Inc
Location Alpharetta, GA
Product Type Devices
Quantity 32,189 cases (20 units per case - 643,780 units) total

Product Description

Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; n. HALYARD* 72 DSE TRACH CARE 12FR; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

Reason for Recall

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.

Lot / Code Information

Product Description, Product code: a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN), 227; b. HALYARD* TRACH CARE-72 DSE ENDO 14FR, 227-5; c. HALYARD* TRACH CARE-72 WET PAK* 14FR, 22701356-5; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR, 2270156-5; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN), 22703; f. HALYARD* TRACH CARE-72 DSE TRACH 14FR, 22703-5; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR, 227036-5; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR, 227101-5; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK), 2271013; j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183; m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5; n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418; p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183; r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5; u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147; w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716; x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603; z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161; ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR, ag. 2271618-5; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR, 22716183-5; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR, 22716186-5; ai. HALYARD* TRACH CARE-72 DSE 16FR, 227161863-5; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR, 227166-5; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 2276; al. HALYARD* TURBO-CLEANING 14FR DSE Endo, 2276-5;

Other Recalls from Halyard Health, Inc

Recall # Classification Product Date
Z-1427-2018 Class II Halyard Closed Suction System for Adults, Doubl... Feb 7, 2018
Z-1429-2018 Class II Halyard Closed Suction System for Adults, Multi... Feb 7, 2018
Z-1277-2018 Class II CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) F... Dec 13, 2017
Z-0120-2018 Class II Halyard Closed Suction System for Adults, 14 F,... Oct 6, 2017
Z-0117-2018 Class II Halyard Closed Suction System for Adults with B... Oct 6, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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